Contract Clinical Research Associate (Canada)

Category: CRA
Job #: 10679
Location: Canada
Job Type: 1099
Rate / Salary Range: Competitive Hourly Rate

Small / Mid-Sized Sponsor is looking for a CRA with Solid Tumor Oncology experience. Sites are located in Eastern Canada, therefore fluency speaking French is required.

Job Responsibilities:
  • Act as the "Site Manager" ensuring relationship with site(s) are positive, issues are resolved quickly, and communications are strong across all verticals.
  • Assist with the development of study manuals, CRFs, monitoring standards, site study tools and other study materials as required.
  • Develop and implement site recruitment, selection and initiation plan.
  • Manage and drive patient recruitment and enrollment tracking.
  • Provide training to sites on the study protocol, study conduct, CRF completion and data management expectations.
  • Ensure essential document collection for completeness per regulatory requirements.
  • Serve as a liaison with Investigators, Institutions and sites to provide support during the conduct of the clinical trial and serve as a resource for protocol and procedures.
  • Demonstrate knowledge of on-site monitoring to ensure compliance with GCPs, study protocols, and SOPs.
    Manage one or multiple studies.
  • Monitor product supplies/accountability including proper storage, dispensation, and disposal.
  • Manage study completion activities including CRF collection, query resolution, record archiving and site closeout activities.
  • Review in-house data and study tables.
  • Mentor, coach and provide guidance to clinical staff as appropriate.
  • Supervise and train other employees as appropriate.
Job Qualifications:
  • Minimum 3 years' experience as a fully dedicated Regional, Home Based, Field Monitor for a CRO or Pharma; this experience should be recent (i.e. - no longer than 2 years ago).
  • Fluency speaking French is Required.
  • Must have at least at least 1 year recent experience monitoring Solid Tumor Oncology studies (any indication).
  • Experience monitoring early phase studies is a plus.
  • Experience monitoring Cancer Stem Cells studies is a plus.
  • Must have at least 50% Utilization available
  • Willing to travel as required. We understand Canada's travel is currently locked down due to Covid. Therefore, travel is restricted at the moment until restrictions are released.
  • Experience with EDC, eTMF or CTMS.
  • Sites are located in Canada.

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